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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Isiris™ a; Isiris™ Monitor; Isiris™ Monitor Fixture; Isiris™ Monitor adaptor kit type G; Isiris™ Monitor adaptor kit-typ
Classification Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Product Code: FAJ
Device Class: 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology
Registered Establishment Name: Centre de distribution Coloplast Le Plessis Pate
Registered Establishment Number: 3012649202
Premarket Submission Number: K160766
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Foreign Exporter
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